CFDA Notice on Standardizing the Function Claims of Health Food and Interpretation of SAMR

On 13 February 2018, former CFDA issued a Notice on Standardizing the Function Claims
of Health Food (hereinafter referred to as the Notice), and the State
Administration for Market Regulation (SAMR) interpreted the relevant matters of
the Notice on 17 April 2018.

1.
Details of the Notice

I. For the health food that have not been
evaluated by human feeding trials, the words of “本品经动物实验评价 (This
product is evaluated through animal test)” shall be added before its health
function claims on the label and package insert.

II. Manufacturers of the approved health
food shall modify the labels and package inserts according to above
requirements when reprinting them. By the end of 2020, all of the health food
labels and package inserts shall be revised according to the requirements of
this Notice.

III. From 1 January 2021, if the labels and
package inserts are not revised according to above requirements, relevant
enterprises will be punished according to relevant regulations in Food Safety
Law of China.

IV. For the health food evaluated by human
feeding trials, the specific evaluation technical requirements and labelling
requirements will be separately prescribed.

2. Highlights!
The interpretation of the Notice

I. For the health food that only evaluated
by animal function test, the relevant health function and the modification
requirements of function claims are as follows:

Health
function

The modification
requirements of function claims

Example

Enhancing immune

The words of “本品经动物实验评价” shall be added before its health function claims on the label
and package insert.

[保健功能]本品经动物实验评价，具有增强免疫力的保健功能。

“[Health function] This product is
evaluated by animal test and has the function of enhancing immune.”

V. Applicants
could revise the labels and package inserts according to the Notice
without any change application with CFDA.

VI. “1
January 2021” mentioned in the Notice is the deadline of selling health food whose labels and package inserts have
not been modified according to the
Notice.

3.
CIRS Comments

I. The labels and package inserts of health
food that are going to register with CFDA shall be designed according to the new
requirements of the Notice.

II. Manufacturers of approved health food：

“1
January 2021” is the deadline for products sales. Therefore,
if the health food contains the 7 functions that only evaluated by animal
function tests (as mentioned in above table), relevant manufacturers could complete
the modification of labels and package inserts in time according to their products
sales cycle, to ensure that the products sold from the year of 2021 have
complied with the requirements of the Notice.

If the health food does not have the 7 health
functions, their labels and package inserts could remain unchanged for the
moment. However, enterprises are recommended to pay attention to the health
food regulations updates in China, so that can timely respond to the change of relevant
policies in the future.

If you have any needs or questions, please contact us at service@cirs-reach.com.